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Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy

NCT04216849 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-12-17

No results posted yet for this study

Summary

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

Conditions

  • Type 2 Diabetes With Renal Manifestations

Interventions

BIOLOGICAL

human umbilical cord mesenchymal stem cells

human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group

OTHER

saline

Saline solution containing human serum albumin will be infused to the control group

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Zhongming Liu, MD · Shanghai East Hospital, Shanghai Tongji University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-02-01
Completion
2022-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216849 on ClinicalTrials.gov